The guidelines section keeps you up to date with respect to the current published guidelines of the pharmaceutical industry.
As per FDA there are 50 title of Electronic Codes Of Federal Regulation (E-CFR) In Pharmaceutical. In this article we will see the all 50 title of electronic code of federal regulation. Electronic Codes Of …
Continue Reading…50 Electronic Codes of Federal Regulation (e-CFR) in pharma
21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature. The guidances are applied to the computerized systems that used to store the electronic data. FDA has …
Continue Reading…Important Difference between 21 CFR part 11 and EU Annex 11
ICH full form: International Council on Harmonisation of a technical requirement for registration of pharmaceutical for human use. ICH is a joint initiative of three different regulatory bodies (USA, Europe, and Japan) as per their region to discuss …
Continue Reading…Understand 14 ICH guidelines in the pharmaceutical in an easy way